Founder, Interim CEO

Dr. Kelner is a tenured Professor at the UCSD School of Medicine, and the co-discover and developer of Illudofulvens including Irofulven and CAP-0121. He has 35 years of oncology drug development and served as CSO & CMO for pharmaceutical companies, as a consultant to companies during acquisition of anticancer agents, and overseen implementation of oncology phase I, II and III trials. He was the principal investigator on research grants totally more than $10 million and served on numerous NIH review committees.

CMC / Regulatory

Dr. Sorenson has over 25 years of experience in the pharmaceutical industry providing Chemistry, Manufacturing and Controls (CMC) leadership of small molecule new chemical entities, including analytical method development & validation and transfers, stability programs and data assessment. Dr. Sorenson was instrumental in guiding Irofulven (first gen drug) through the FDA regulatory process to obtain IND approval.

Pharma / Toxicology

Dr. Trost has over 25 years of experience in development strategy, design, execution, and reporting of GLP-compliant ADME, toxicology and animal studies for regulatory submissions. He has conducted over 300 GLP-compliant studies and has experience in authoring briefing documents and presentations to the FDA, and is now guiding CAP-0121 through the regulatory process.

Clinical / Regulatory

Ms. Smith has over 30 years of clinical research experience in the pharmaceuticals. She served as President of Courante Oncology, a specialty consulting company providing customized clinical oncology research services. Ms. Smith was the Senior Director of Clinical Operations at MGI Pharma, where she oversaw the clinical development of Irofulven (first gen drug) including oversight of clinical operations, data management, statistics, and regulatory documentation.